When it comes to selecting a biostatistical CRO, most sponsors choose to work with the cheapest proposal. But that’s a mistake and your organization will pay dearly for it in the long run. Not only does the lowest bid frequently come with a number of hidden costs and overages, there’s also the small matter of […]
/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svg00princeadmin/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svgprinceadmin2018-05-01 11:20:012018-05-01 11:20:01Regulatory Compliance Has No Tolerance for Error
What’s on the horizon: mandatory FDA PDUFA V Per PDUFA V Commitment, FDA shall issue final guidance on the standards and format of electronic submission of drug marketing application by end of 2014. All new original NDA and BLA submissions, supplements and amendments are required to follow the final guidance by end of 2016. All […]
/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svg00princeadmin/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svgprinceadmin2014-03-08 16:54:102014-03-08 16:54:10Prepare now for adoption of ADaM standard
Regulatory Compliance Has No Tolerance for Error
in Approval Glitches / ProblemsWhen it comes to selecting a biostatistical CRO, most sponsors choose to work with the cheapest proposal. But that’s a mistake and your organization will pay dearly for it in the long run. Not only does the lowest bid frequently come with a number of hidden costs and overages, there’s also the small matter of […]
Prepare now for adoption of ADaM standard
in Getting FDA ApprovalWhat’s on the horizon: mandatory FDA PDUFA V Per PDUFA V Commitment, FDA shall issue final guidance on the standards and format of electronic submission of drug marketing application by end of 2014. All new original NDA and BLA submissions, supplements and amendments are required to follow the final guidance by end of 2016. All […]